Noël Ny Tovo

• • Lead the global clinical operations activities, ensure effective decision making and acts as point of contact for resolution of issues with the region for assigned countries.

• • Contribute to the Clinical Development Plan, the study Protocol Development Plan (CDP).

• • Lead external vendors involved in the study (Central lab, eCOA/PRO, IVRS, ECG, …),

• • Oversee the execution of the study from the set-up to the end of trial by collaborating with the key stakeholders at global and regional level. Provide regular updates on study progress during the Clinical Trial Team meeting.

• • Develop study tools, guidelines and training materials. Provide trainings to the regional clinical trial team.

• • Lead operations meetings with regional study team members.

• • Ensure deep collaboration with the regions and countries.

• • Contribute and update the different systems used to run the study, the Clinical Trial Management System (CTMS), the Clinical Data Management System (CDMS), the Clinical Documents Management System (CDMS).

• • Ensure a high-level quality of the Trial Master Files (TMF) at HQ, countries and sites level by a regular review and update of files.

• • Support the database lock and CSR preparation including the TMF submission readiness for CSR submission to Health Authorities.

• • Service provider for Pharma company, IT in recruiting highly talented people.

• • Headhunter and advisor of candidates who are looking for a new position.

Therapeutic Area: Oncology/Multiple Myeloma

• • Ensures regional and global clinical operations deliverables progress according to the agreed timelines and milestones as the leader of the Study Management Team within Global Clinical Operations GCO.

• • Leading operational trial planning and management, collaborating as a key partner within the cross functional trial team.

• • Ensure deep collaboration with the regions and countries.

• • Act as point of contact between the Global Clinical team and the regional or country team